MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1ZZ*FX25E

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Lot number: second potential lot number- 180625.Expiration date - for second potential lot number- 31may2021.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - for second potential lot number- 25jun2018.Pma/510k: 510(k) - k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.(b)(4).

Event Description

The user facility reported that the involved capiox device was used; surgery aortic valve in bypass started at 09.46 am.It was impossible to keep the po2 on a good level.Co2 was not eliminated in a good level.Despite of increasing po2 it was not possible to increase the si o2.At 10.34 am decision to change the oxygenator.They had to stop hlm for 90 seconds (patients esophagus temperature 33.4).After changing the oxygenator everything went well and surgery could be finished at 11.47 am.No delta p.The patient has been extubated same day and their condition was good.The procedure outcome was not reported.

Manufacturer Narrative

The actual device was not returned to the manufacturing facility for evaluation.Two factory-retained samples from the two code/lot combinations involved in this issue were evaluated.Visual inspection revealed no obvious anomaly that could lead to the poor gas transfer, such as a break in the appearance.The retention samples were tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.Bovine blood arranged to (hb12.0 g/dl, temp.37-deg.C., ph: 7.4, svo2: 65% and pvco2: 45mmhg) circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 6l/min.And 4l/min.Lot 180622: o2 transfer: @6l/min.=385ml/min.@4l/min.= 278ml/min.Co2 removal: @6l/min.= 326ml/min.@4l/min.= 225ml/min.Lot 180625: o2 transfer: @6l/min.=392ml/min.@4l/min.= 282ml/min.Co2 removal: @6l/min.= 337ml/min.@4l/min.= 240ml/min.No anomalies were revealed in the gas transfer performance of the retention samples, with the obtained values meeting manufacturer specifications.Ifu states: start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.A phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention samples.The investigation result verified that the retention samples of the involved product code/lot combinations were the normal products with no issue in the gas transfer performance.It is likely that due to low fio2, pao2 did not increase and neither did svo2; due to prolonged stand-by period before the ecc started, wet lung phenomenon occurred and water drops generated in the gas channel, which prevented gases from contacting blood sufficiently leading to poor gas transfer.However, with no device return and the involved pump record and detailed information on the occurrence condition were not available, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.It was reported that the device was no longer available; however, the device was received.Two potential lot numbers were initially reported; however, upon the receipt of the actual device, the lot number was confirmed.Therefore, section d4 has been updated to reflect lot number 180625.The actual sample was received for evaluation.Visual inspection revealed no obvious anomaly, such as a break, which could have led to the poor gas transfer performance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance.Bovine blood arranged to (hb: 12.0 g/dl, temp.: 37°c., ph: 7.4, svo2: 65% and pvco2: 45mmhg) circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 6l/min.And 4l/min.Results: o2 transfer: @6l/min.= 386ml/min.@4l/min.= 278ml/min.Co2 removal: @6l/min.= 324ml/min.@4l/min.= 244ml/min.No anomalies were revealed in the gas transfer performance, with the obtained values meeting the manufacturer specifications.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that due to low fio2, pao2 did not increase and neither did svo2; due to prolonged stand-by period before the ecc started, wet lung phenomenon occurred and water drops generated in the gas channel, which prevented gases from contacting blood sufficiently leading to poor gas transfer.However, since the involved pump record and detailed information on the occurrence condition were not available, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9171286
• MDR Text Key: 161667742
• Report Number: 9681834-2019-00176
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 1ZZ*FX25E
• Device Lot Number: 180622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other